Bruker Corporation

  • Quality Assurance and Regulatory Affairs (QA/RA) Manager (m/w/d)

    Job Locations DE-BW-Ettlingen
    Posted Date 2 weeks ago(2 weeks ago)
    Req. #
    2018-6491
    # of Openings
    1
    Position Type
    Regular Full-Time
  • Overview

    As one of the world’s leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, accelerate time-to-market and support industries in successfully enhancing quality of life. We’ve been driving innovation in analytical instrumentation for 50 years now. Today, worldwide more than 6,000 employees are working on this permanent challenge, at over 70 locations on all continents.

     

    Responsibilities

    The Quality Assurance and Regulatory Affairs (QA/RA) Manager (m/w) will support the execution of various Q&RA programs/projects that support the BBIO business strategy and tactical plans as well as helping to mentor and coach the existing Q&RA team

    • Provide QA/RA leadership across key departments within BBIO
    • Train company employees on compliance with quality system standards such as 21 CFR 820 and ISO 13485.
    • Mentor/coach for QA Managers and RA Manager
    • Ensure company is regulatory inspection (FDA, Notified Body, international regulatory bodies, corporate) ready at all times.
    • Plan, coordinate and direct regulatory strategies for new products/prepare 510(k)s/de novo 510(k)s/pre-subs for IVD product
    • Lead/support effort to bring IVD product into China
    • Lead/support CAPA activity
    • Lead/support Quality initiaitives

    Qualifications

    • Minimum bachelor's degree in scientific discipline
    • Minimum 3-5 years in regulatory affairs/quality assurance with 510(k) experience in Life Sciences company
    • Experience with the following standards: ISO 9001/ISO 13485/cGMPs/21 CFR Part 11/IVD Directive/GLPs
    • Statistical proficiency/lean/six sigma desirable
    • Fluent in both English and German
    • Team Player with a hands on mentality and high customer orientation

     

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